Understanding State Board Regulations Providing Compassionate Care While
Understanding State Board Regulations: Providing Compassionate Care While Avoiding Common Mistakes Joe Y. Kim, MD Water’s Edge: Memorial’s Pain Relief Institute
Washington State • Follows Model Policy on the Use of Opioid Analgesics in the Treatment of Chronic Pain • Federation of State Medical Boards • July 2013 (1997, 2003)
Washington State • Since 2004 • 1 in 4 in primary care settings, pain limits ADL’s • Undertreatment of pain is serious public health problem
Inappropriate Management • Inadequate initial assessment for clinical indication • Inadequate monitoring • Inadequate attention to patient education/consent • Unjustified dose escalation: risks? alternatives?
Discipline • “Physicians should not fear disciplinary action from the Board for ordering, prescribing, dispensing or administering controlled substances, including opioid analgesics, for a legitimate medical purpose and in the course of professional practice, when current best clinical practices are met. ”
Discipline • “The Board will not take discplinary action against a physician for deviating from this Model Policy when contemporaneous medical records show reasonable cause for such a deviation. ” • “The board will judge the validity of the physician’s treatment of a patient on the basis of available documentation, rather than solely on the quantity and duration of medication administered”.
Guidelines • Understanding Pain: • Patient Evaluation and Risk Stratification • Development of a Treatment Plan/Goals • Informed Consent/Treatment Agreement
Guidelines • Initiating an Opioid Trial • Ongoing Monitoring and Adapting the Treatment Plan • Periodic Drug Testing • Consultation and Referral
Guidelines • Discontinuing Opioid Therapy • Medical Records • Compliance with Controlled Substance Laws and Regulations
Methadone • Increased rate of methadone related deaths • QTc: pre, 3 days, annual • 450 -500 ms discuss (debate) • “No evidence has been found to support the use of the EKG for preventing cardiac arrhythmias in methadone-treated opioid dependents” Cochrane investigators
Methadone • Follow up sooner after: • • Initiation or increase Pharmacodynamics/kinetics • Analgesic action 6 hrs (morphine is opposite) • Full analgesic effects • • Morphine conversion median 5 days (range 4 -13) • May be 1 -2 weeks Long half-lfe/accumulation ==> delayed toxicity
Methadone • Equianalgesic for repetitive dosing smaller than single-dose • 65 y/o decreased clearance • No liver adjustments • Metabolites do not accumulate with renal failure
Methadone • Increased rate of methadone related deaths
What is the ideal opioid? • half-life, side effects, metabolites, etc…
What is the ideal opioid? Oxycodone No ceiling dose Minimal side effects Absence/minimal activce metabolite Easy titration Rapid onset Short half-life Long duration Predictable pharmacokinetics
Random Considerations • T 3/T 4: ceiling effect 60 mg/dose, max 360 mg/day • Hyrdocodone: maximal daily 60 mg/day? • Morphine: renal failure (M 6 G); rectal? • Oxymorphone: hepatic impairment
Random Considerations • Tapentadol (Nucynta): seizures, ICP, asthma • inhibit serotonin/NE reuptake • Tramadol: 5 HT, cardiovascular, seizures, addiction • TCA/MSO 4: synergistic CNS/respiratory depression
Guidelines • Patient Evaluation and Risk Stratification • • Indication/Evaluation Assessment • Nature, intensity, treatments, comorbidities, function. • ROS, SH, FH (abuse), PE, labs? , SOAPP-R, ORT • All patients should be screened for depression/mental health
Guidelines • Assessment • History of substance abuse: failure/harm • • If possible, consult before therapy initiated. Current abuse • Established in treatment/recovery program • Co-managed with addictions specialist
Terms • Tolerance • Dependence • Abuse • Addiction
Guidelines • Assessment • Brings in own pile of records • • ask for records directly PMP
Guidelines • Development of a treatment plan/goals • • • Goals • Improvement of pain and function • Improvement of pain associated symptoms Avoidance of unnecessary/excessive use of meds Revisited regularly
Guidelines • Development of a treatment plan/goals • Individualized • Supports selection of treatment • Objectives to evaluate progress • pain relief • physical/psychosocial function
Guidelines • • Informed consent • Risks/benefits • Why change Treatment agreement • Goals • Patient’s/physician’s responsibilities
Guidelines • Informed consent/Treatment agreement • Shared decision • Store/disposal
Guidelines • Initiating an Opioid Trial • Present as a trial (e. g. 90 days) • Evaluate benefit (pain/fxn/QOL) vs. harm • Lowest possible start dose • Short acting
Guidelines • Ongoing Monitoring and Adapting the Treatment Plan • Collateral information: family, close contacts, PMP • More frequently at first • Five A’s: Analgesia, Activity, Adverse Effects, Aberrancy, Affect/mood
Guidelines • Ongoing Monitoring and Adapting the Treatment Plan • Continue? • Progress towards goals (pain, fxn, QOL) • Absence of risks/adverse events
More meds • Psychotherapy • Rehabilitative • Injection • Surgery • Medications
More meds • Anti-inflammatory • Antidepressants • Membrane stabilizers • Muscle relaxants • Opioids
Escalations • Can be a sign of use disorder/diversion • • Good time to get UDS “halftime” rule
High doses • 200 mg (MED) in 2010, lower now • Concerns • Hyperalgesia • Neuroendocrine • Immunosuppression
Guidelines • Periodic Drug Testing/Screening • Clinical judgement > recommendations • Discuss in supportive fashion • Pill count “useful” • PMP “highly recommended”
Opioid Rotation • Intolerable side effects • Inadequate benefit • 25 -50% reduction
Rotation • Total 24 -hour dose • Calculate new dose • 50 -65% got incomplete cross-tolerance • Consider rescue
Rotation • Fentanyl 50% decrease in 17 hours • Calculate new dose • 50 -65% got incomplete cross-tolerance • Consider rescue
Guidelines Periodic Drug Testing/Screening • • Unsatisfactory progress • Intervention needed: • early refill • multiple lost/stolen rx • physician shopping • intoxication/impairment • pressuring/threatening behavior • illicit/unprescribed drugs
Guidelines • Periodic Drug Testing/Screening • Intervention needed: • Behavior suggesting RECURRING misuse • self-increase dose • deteriorating function • failure to comply to the treatment plan
Guidelines • Periodic Drug Testing • “Firm response” • Forgery • Obvious impairment • abusive/assaultive behavior
Transit times (inexact) Rapid: • • Et. OH 7 -12 hrs • Pentobarbitol (24 h) • Propoxyphene 6 -48 hrs
Transit times Fast: • • (Meth) Amphetamine 48 hrs • Codeine 48 hrs • Heroine 48 hrs • Cocaine metabolites 2 -4 days • Hydromorphone 2 -4 days • Methadone 3 days • Short-acting BZ’s 3 days • Long-term/heavy 30 d
Transit times Long • • PCP 8 days • Phenobarbital 3 wks • Long-acting BZ’s 30 days
Guidelines • Consultation and Referral • • Pain, psychiatry, addiction, or mental health specialist “if needed” • History of substance abuse • Co-occuring mental health disorder Know treatment options in treatment programs for addictions
Guidelines Discontinuing Opioid Therapy • • Regularly weigh benefits/risks • Discontinue • resolution • intolerable side effects • inadequate analgesia • failure to improve QOL • significant aberrancy
Guidelines • Discontinuing Opioid Therapy • Structured tapering regimen • Withdrawal • • Addiction specialist or physician Not the end (direct care or referral)
Weaning off • Repeated aberrant drug-related behaviors • Diversion • Intolerable side effects • No progress towards goals
“More Serious” • Repeatedly non adherent • Cocaine • Unprescribed opioids • Doctor Shopping • Unprescribed opioids • Morphine example
“Non-serious” • 1 -2 unauthorized dose escalations • Alcohol
Wean off • Rehabilitation setting ideal • Addiction treatment made available • Follow-up • Non-opioid pain management
Wean off • Slow: 10%/ week • Rapid: 25 -50% every few days • At higher doses, can be more rapid • When get to lower doses, slow down
Guidelines • Medical Records • Copies of the signed informed consent and treatment agreement • Patient’s medical history • Results of physical exam and laboratory tests • Results of risk assessment (e. g. screen tools) • Description of treatments provided • Instructions to the patient (e. g. risks, benefits)
Guidelines • Medical Records • Results of ongoing monitoring of patient progress (pain/fxn) • Notes on evaluation/consultations of specialists • Any other supporting information to support • Authorization of release of information
Universal Precautions • 1. Make a diagnosis with an appropriate differential • 2. Conduct a patient assessment, including risk for substance use disorders • 3. Discuss the proposed treatment plan with the patient and obtain informed consent • 4. Have a written agreement that sets forth the expectations and obligations of both the patient and treating physician • 5. Initiate an appropriate trial of opioid therapy, with or without adjunctive medications
Universal Precautions • 6. Perform regular assessments of pain and function. • 7. Reassess the patient’s pain score and level of function • 8. Regularly evaluate the patient in terms of the “ 5 A’s” • 9. Periodically review the pain diagnosis and any comorbid conditions (including substance use disorders) and adjust the treatement regimen accordingly • 10. Keep careful and complete recored of the initial evaluation and each follow up visit.
State Website • Can I drink alcohol while taking pain medication? • • “Talk to your healthcare provider. Alcohol may have unintended consequences…” If a patient has been at 140 mg MED for several years, do I need to consult a pain specialist? • “No, For a patient with stable pain and function, on a non-escalating dosage of opioids, the consultation requirement would not be required as long as the practitioner documents these items. ”
Scoping the Addict • Most strongly predictive factor: • personal/family history of alcohol/drug abuse. • Younger • Psychiatric history
Scoping the Addict • Travel • Escalation of dose • Focus on one medication • Affect • End of week refill
The “High Risk Patient” • History of drug abuse • Psychiatric issues • Serious aberrant drug-related behaviors
The “High Risk Patient” • Benefits outweigh risks • “Strongly Consider” • Mental health specialist • Addiction specialist
The “High Risk Patient” • Referral/change/discontinue • Precise prescription • 4 strikes and you’re out:
How often to visit with? • Stable, Low risk: 3 -6 months • High risk: up to weekly • addictive disorder • job requiring mental acuity • elderly • social/psychiatric/medical
The “High Risk Patient” • Change • More frequent/intense • Tapering (permanent/temporary) • Psychological therapies • Nonopioid treatment
The “High Risk Patient” • Discontinue • Diversion, forgery, stealing/buying • Serious aberrant behavior • • Injecting oral meds Dangerous/suicidal behavior
Driving • • Effects (Especially at first, with increases, or mixed) • Somnolence • Clouded mentation • Decreased Concentration • Slower reflexes/incoordination Studies don’t show increase accidents
Driving • A person is guilty of driving while under the influence of intoxicating liquor or any drug if the person drives a vehicle within this state: While the person is under the influence of or affected by intoxicating liquor or any drug; or While the person is under the combined influence of or affected by intoxicating liquor and any drug.
Driving • A person is guilty of negligent driving in the first degree if he or she operates a motor vehicle in a manner that is both negligent and endangers or is likely to endanger any person or property, and exhibits the effects of having consumed liquor or an illegal drug. • However, legal entitlement to use the drug is a defense to the charge of “negligent driving” [§ 46. 61. 5249 (1)(a)] if the defendant had a valid prescription for the drug consumed and had been consuming the drug according to the prescription directions and warnings.
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